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Stability Studies - WHO
(API) or Finished Pharmaceutical Product (FPP) varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. The ... multisource (generic) finished pharmaceutical product (FPP) has been revised: Preparation of Product Dossiers (PDS) in Common Technical Document (CTD) format
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Annex 2 WHO good practices for pharmaceutical …
www.who.int71 Introduction and scope of document Pharmaceutical microbiology laboratories may be involved in: — sterility testing; — detection, isolation, enumeration and identifi cation of microorganisms
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Annex 3 WHO good manufacturing practices for ...
www.who.int96 Introduction The fi rst WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth
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database.ich.orgfor a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part4) and WHO guidelines (on the active pharmaceutical ingredient master file procedure (5). It is recommended that these …